vaccine therapy and gm-csf in treating patients with progressive non-hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: vaccines made from a person's cancer cells may make the body build an effective immune response to kill cancer cells. colony-stimulating factors, such as gm-csf, may increase the number of immune cells found in bone marrow or peripheral blood and may stimulate the immune system in different ways and stop cancer cells from growing. purpose: this phase ii trial is studying how well giving vaccine therapy together with gm-csf works in treating patients with progressive b-cell non-hodgkin's lymphoma.

objectives: primary * provide treatment with autologous immunoglobulin idiotype-klh conjugate vaccine (favid)™ and sargramostim (gm-csf) to patients with progressive grade 1, 2, or 3 follicular b-cell non-hodgkin's lymphoma who did not receive favid™ while enrolled on protocol fav-id-06. secondary * determine the response rate and duration of response in patients treated with this regimen. * determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen. * determine the time to progression in patients treated with this regimen. * determine the safety of this regimen in these patients. outline: this is a multicenter study. patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol fav-id-06 (disease progression after prior rituximab and never randomized vs disease progression after randomization to placebo arm). patients receive autologous immunoglobulin idiotype-klh vaccine subcutaneously (sc) on day 1. patients also receive sargramostim (gm-csf) sc on days 1-4. treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity. patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year (6 treatments) and every 3 months until disease progression. after completion of study treatment, patients are followed for 30 days or until the start of subsequent treatment. projected accrual: approximately 238 patients (67 in group i and 171 in group ii) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed follicular b-cell non-hodgkin's lymphoma (nhl) * grade 1, 2, or 3 * progressive disease and did not receive autologous immunoglobulin idiotype-klh conjugate vaccine (favid™) while enrolled on protocol fav-id-06 * meets 1 of the following criteria: * received salvage therapy after completion of protocol fav-id-06 * at least 4 weeks, but no more than 4 months, since prior salvage therapy * did not receive salvage therapy after completion of protocol fav-id-06 * at least 4 weeks, but no more than 4 months, since completion of prior treatment on protocol fav-id-06 * no history of cns lymphoma or meningeal lymphomatosis patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified cardiovascular * no history of congestive heart failure pulmonary * no history of compromised pulmonary function other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * hiv negative * no active bacterial, viral, or fungal infection * no psychiatric disorder * no other serious nonmalignant disease that would preclude study participation prior concurrent therapy: biologic therapy * see disease characteristics * no prior allogeneic transplantation\* * no prior rituximab regimen\* other than that administered on protocol fav-id-06 (rituximab 375 mg/m\^2 iv weekly for 4 weeks) chemotherapy * no prior purine analogues\* (e.g., fludarabine or cladribine) endocrine therapy * no prior or concurrent steroids (e.g., steroid doses in excess of daily replacement) radiotherapy * not specified surgery * not specified other * recovered from prior salvage therapy * no prior or concurrent immunosuppressive therapy * no prior investigational agents\* * no other concurrent antilymphoma therapy note: \*as salvage therapy administered between completion of protocol fav-id-06 and enrollment onto this study

Keywords: recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma